Combined Pulsed Dye Laser and Topical Ranibizumab for Treatment of Port Wine Stain Birthmarks

Port-Wine Stain Clinical Trial

Official title:

Combined Pulsed Dye Laser and Topical Ranibizumab for Treatment of Port Wine Stain Birthmarks

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00667472
• Other study ID #: 20076098
• Status: Withdrawn
• Phase: Phase 1
• Start date: March 2008
• Est. completion date: November 2013

Study information

• Verified date: October 2022
• Source: University of California, Irvine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to improve port wine stain therapeutic outcome in response to laser therapy. The researcher want to determine whether the combined use of pulsed dye laser therapy and topical ranibizumab will improve port wine stain therapeutic outcome.

Description:

Combined use of pulsed dye laser to induce port wine stain blood vessel injury, and ranibizumab to prevent port wine stain blood vessel angiogenesis and recanalization after laser therapy, will improve port wine stain lesion blanching. After pulsed dye laser treatment of the entire port wine stain, topical ranibizumab will be applied to two of the test sites for two weeks following pulsed dye laser therapy. The degree of port wine stain blanching which will be quantified objectively using visible reflectance spectroscopy measurements. port wine stain test site blanching responses following the combined use of pulsed dye laser and topical ranibizumab will be compared with pulsed dye laser only and with the baseline controls.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: November 2013
• Est. primary completion date: November 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Port Wine Stain suitable for comparison testing
• Age > 18 years of age

Exclusion Criteria:

• History of photodermatoses or skin cancer
• use of known photosensitizing drugs
• use of immunosuppressive drugs or systemic steroids
• Pregnancy

Related Conditions & MeSH terms

• Hemangioma, Capillary
• Port-Wine Stain

Intervention

Drug:
• Ranibizumab
Combined Pulsed Dye Laser and Topical Ranibizumab for Treatment of Port Wine Stain Birthmarks

Device:
• Pulsed Dye Laser
Combined Pulsed Dye Laser and Topical Ranibizumab for Treatment of Port Wine Stain Birthmarks

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of California, Irvine	Beckman Laser Institute University of California Irvine

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Port Wine Stain response to laser treatment	Combined Pulsed Dye Laser and Topical Ranibizumab for Treatment of Port Wine Stain Birthmarks	8 weeks